机构地区:[1]Cancer Center,The First Hospital of Jilin University,Changchun,Jilin 130021,China [2]Institute of Translational Medicine,The First Hospital of Jilin University,Changchun,Jilin 130021,China [3]Amoy Diagnostics Co.,Ltd,Xiamen,Fujian 361000,China
出 处:《Chinese Medical Journal》2021年第20期2430-2437,共8页中华医学杂志(英文版)
基 金:supported by the National Key Research&Development Program of China(No.2016YFC1303800);Innovation Project of Health and Technology in Jilin Province(No.2017J064);Special Project of Development and Reform Commission in Jilin Province(No.2017C022);Key Laboratory Construction Project of Department of Science and Technology of Jilin Province(No.20170622011JC)。
摘 要:Background:Circulating tumor DNA(ctDNA)is a promising biomarker for non-invasive epidermal growth factor receptor mutations(EGFRm)detection in lung cancer patients,but existing methods have limitations in sensitivity and availability.In this study,we used theΔCt value(mutant cycle threshold[Ct]value-internal control Ct value)generated during the polymerase chain reaction(PCR)assay to convert super-amplification-refractory mutation system(superARMS)from a qualitative method to a semi-quantitative method named reformed-superARMS(R-superARMS),and evaluated its performance in detectingEGFRm in plasma ctDNA in patients with advanced lung adenocarcinoma.Methods:A total of 41 pairs of tissues and plasma samples were obtained from lung adenocarcinoma patients who had knownEGFRm in tumor tissue and were previously untreated.EGFRm in ctDNA was identified by using superARMS.Through making use ofΔCt value generated during the detection process of superARMS,we indirectly transform this qualitative detection method into a semi-quantitative PCR detection method,named R-superARMS.Both qualitative and quantitative analyses of the data were performed.Kaplan-Meier analysis was performed to estimate the progression-free survival(PFS)and overall survival(OS).Fisher exact test was used for categorical variables.Results:The concordance rate ofEGFRm in tumor tissues and matched plasma samples was 68.3%(28/41).At baseline,EGFRm-positive patients were divided into two groups according to the cut-offΔCt value ofEGFRm set at 8.11.A significant difference in the median OS(mOS)between the two groups was observed(EGFRmΔCt≤8.11vs.>8.11:not reachedvs.11.0 months;log-rankP=0.024).Patients were divided into mutation clearance(MC)group and mutation incomplete clearance(MIC)group according to whether theΔCt value ofEGFRm test turned negative after 1 month of treatment.We found that there was also a significant difference in mOS(not reachedvs.10.4 months;log-rankP=0.021)between MC group and MIC group.Although there was no significant differenc
关 键 词:Lung adenocarcinoma Non-small cell lung adenocarcinoma Liquid biopsy Super-amplification-refractory mutation system EGFR mutation
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